Details for New Drug Application (NDA): 211287
✉ Email this page to a colleague
NDA 211287 describes TIOTROPIUM BROMIDE, which is a drug marketed by Lupin and is included in one NDA. It is available from one supplier. Additional details are available on the TIOTROPIUM BROMIDE profile page.
The generic ingredient in TIOTROPIUM BROMIDE is tiotropium bromide. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tiotropium bromide profile page.
The generic ingredient in TIOTROPIUM BROMIDE is tiotropium bromide. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tiotropium bromide profile page.
Summary for 211287
| Tradename: | TIOTROPIUM BROMIDE |
| Applicant: | Lupin |
| Ingredient: | tiotropium bromide |
| Patents: | 0 |
Pharmacology for NDA: 211287
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 211287
Suppliers and Packaging for NDA: 211287
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TIOTROPIUM BROMIDE | tiotropium bromide | POWDER;INHALATION | 211287 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-964 | 68180-964-12 | 3 BLISTER PACK in 1 CARTON (68180-964-12) / 10 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | EQ 0.018MG BASE/INH | ||||
| Approval Date: | Jun 20, 2023 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
